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Adult Stem Cell Therapy in Liver Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147043
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 12, 2016
Information provided by:
Imperial College London

Brief Summary:

In order to determine the clinical application potential of adult stem cells we propose to investigate the safety and toxicity of infusing adult stem cells in the hepatic artery or portal vein of five patients with chronic liver insufficiency and to identify any clinical benefit if such occurs.


  1. To assess safety and treatment related toxicities
  2. To determine clinical benefit or deterioration by monitoring changes in liver function

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Procedure: Leukapheresis Procedure: Infusion of stem cells via image guided scan Phase 1

Detailed Description:

The liver in an adult healthy body maintains a balance between cell gain and cell loss. Though normally proliferatively quiescent, hepatocyte loss such as that caused by partial hepatectomy, uncomplicated by virus infection or inflammation, invokes a rapid regenerative response to restore liver mass. This restoration of moderate cell loss and 'wear and tear' renewal is largely achieved by hepatocyte self-replication. More severe liver injury can activate a potential stem cell compartment located within the intrahepatic biliary tree, giving rise to cords of bipotential, so-called, oval cells within the lobules that can differentiate into hepatocytes and biliary epithelial cells. A third population of stem cells with hepatic potential reside in the bone marrow; these haematopoietic stem cells can contribute to the albeit low renewal rate of hepatocytes, make a more significant contribution to regeneration and even completely restore normal function in a murine model of hereditary tyrosinaemia.

A recent abstract has suggested that an astonishingly high number of bone marrow cells (~25% of liver parenchyma occupied by bone marrow-derived cells) will engraft and differentiate into hepatocytes in a model of cirrhosis in the mouse when injected intravenously. More importantly, this bone marrow infusion resulted in significant improvements in liver function (serum albumin) within the cirrhotic animals.

This is a safety and toxicity study in five patients with chronic liver disease. Each will receive autologous stem cells 10 to the sixth cells via the hepatic artery or portal vein under image guided scanning. Patients will be followed for a total of 60 days.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adult Stem Therapy for Patients With Liver Insufficiency
Study Start Date : January 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To assess safety and treatment related toxicities

Secondary Outcome Measures :
  1. To determine clinical benefit or deterioration by monitoring changes in liver function

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Male or female aged from 20 years to 65 years Evidence of chronic liver failure Abnormal serum albumin and/or bilirubin and/or prothrombin time Unsuitable for liver transplantation WHO performance status <2 Women of childbearing potential may be included but must use a reliable and appropriate contraceptive method Life expectancy of at least three months Ability to give informed consent

Exclusion Criteria:

- Patients aged below 20 years or above 65 years Pregnant or lactating women Patients with recent recurrent gastrointestinal bleeding Spontaneous bacterial peritonitis Evidence of active infection HIV infection Patients unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147043

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United Kingdom
Hammersmith Hospitals NHS Trust
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Nagy Habib, ChM FRCS Imperial College London

Layout table for additonal information Identifier: NCT00147043     History of Changes
Other Study ID Numbers: 2004/6746
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: September 2005

Keywords provided by Imperial College London:
Adult stem cells
Liver disease
CD34 positive cells

Additional relevant MeSH terms:
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Liver Cirrhosis
Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases